manufacturing process | Seabrook Technology Group

manufacturing process | Seabrook Technology Group

Realize Live 2019 Learning Points: The Four Questions to Ask at the Inception of Digital Transformation

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Participation in large educational and networking events can be rewarding – or exhausting – or maybe a bit of both.  While networking and catching up with old friends (or making new ones) is often what is remembered, I want to take a few moments to highlight an important learning point that I absorbed at Realize Live in Detroit this month (June 10-13, 2019). 

The ever-changing landscape in the healthcare industry has placed abounding pressure on medical device manufacturers. Change is consistent in all industries. Rate of change, however, has increased dramatically in recent years – and nowhere is this more evident than in MedTech, as digitalization is becoming vital to manufacturing processes. 

According to a late 2018 poll in Today’s Medical Developments magazine, the following pressures were listed by medical device manufacturers as “most pressing:”

  • Pricing pressures
  • Access to funding
  • Changing regulatory environment
  • Retaining/growing a skilled workforce
  • New product development
  • Increased market competition
  • Ability to invest in technology

–  www.todaysmedicaldevelopments.com. 12.28.18

The medical device market is experiencing and extreme burden to innovate – not only with new products, but also with new processes.  While large medical device manufacturers continue move forward in a digitally-evolving industry, the Small-To-Medium Medical Device Manufacturer (SMB) is entangled at a crossroads of status quo (with a risk of becoming obsolete) vs. transformation into the digital manufacturing landscape (with initial financial investment, but a hopefully-rapid ROI).   

For manufacturers of all sizes, creating a collaborative, connected manufacturing process improves quality and reduces time and expense.  Moving an enterprise from digitalization concept to established business practice, however, can be daunting.  According to Siemens Digital Enterprise Consultants T. Doering and H. Sand at Realize Live 2019, SMBs must thoroughly understand the transition before they begin to plan and implement this transformation to digital manufacturing. To fully understand this transition, an SMB must ask and answer the following:

  • Why:  Why transition to digitalization? What are the primary drivers for the organization to transform to a digital manufacturing environment (i.e. cost, efficiency, customer demand)?
  • What:  What is the organization’s current state (financial health, culture, etc.) and target for completion (what will be considered “successful” implementation)?
  • When:  When will this transition be completed? What is the organization’s timeline for transformation – and what steps need to be taken to complete this timeline?  Is there a “road map” for the organization’s digital transformation?
  • How:  How does digital transformation align to the goals of the organization?  How will digitalization coincide with strategic initiatives?  How does the digitalization process begin – and with what projects?

 – Realize Live, Digital Enterprise Consulting.  Timo Doering and
Hans Christian Sand.  June 11, 2019

Introduction of a Manufacturing Execution System (MES) can begin to answer some of these questions, and Opcenter Execution Medical Device and Diagnostic (formerly CamstarTM Medical Device Suite) is industry top-of-the-class.  Opcenter Execution MDD enables medical device and diagnostics manufactures to meet the challenges of product quality and compliance – without sacrificing profit.

Opcenter Execution MDD (formerly CamstarTM Medical Device Suite)

  • creates a paperless manufacturing environment,
  • enforces industry best practices and compliance,
  • eliminates non-value-added activities, and
  • creates self-auditing electronic Device History Records (eDHR) and Electronic Batch Records (eBR)

leading to more rapid time-to-market, greater flexibility and agility, improved product quality, safety and reliability, and increased efficiency (effectively lowering costs).

It has been our experience that companies that utilize Opcenter Execution MDD can quickly realize powerful reduction in paper cost, cycle times, manufacturing-related complaints, scrap, product review and release time. In addition to the many benefits, the ease of implementation is often painless, regardless of the size and scope of the enterprise.  Additionally, as a leader in the industry, Opcenter Execution MDD is small-business friendly and serves an extensive customer base with enormous success.

In our next blog, we will address a trending topic among Realize Live attendees (and many in the medical device manufacturing industry):  Compliance vs. Innovation – Are They Mutually Exclusive?  Look for this article coming soon!

Questions about transforming your manufacturing to a digital environment?  Seabrook Technology Group celebrates its 30th year in 2019!  Consisting of a team of global experts and industry thought leaders, Seabrook brings end-to-end manufacturing solutions (people, processes, technology) together in a harmonized fashion to enable operational excellence for medical device manufacturers.  Our team consists of MESA Certified Consultants​, a CamstarTM Certified Team​, APICS, CPIM Certified Consultants​, PMP Certified Consultants​, and FDA Regulation Experts.  Our entire team brings their passion for Integration, Manufacturing Intelligence and DHR Requirements skillsets to their work.  Seabrook Technology Group is a global, privately held company which was founded in 1989.   ​

IRELAND OFFICE (HQ):  Mainline Place, Sarsfield Rd., Wilton, Cork, T12 DY80, Ireland  Tel: +353 21 4800 840 | [email protected]

INDIANA OFFICE: 600 Corporation Drive, Suite # 108, Pendleton, Indiana 46064, USA Tel: +1 317 426 0699 | [email protected]

End-to-End Manufacturing Solutions for Medical Device Manufacturers: Camstar Medical Device Suite

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The manufacturing industry is often regarded as one at the forefront of technology adoption.  There are many manufacturers, however, who continue to rely on a paper-driven process.  This is especially prevalent in the small-to-medium medical device and biotech manufacturing industries. 

Manufacturing, by nature, is a process-centric industry, so the transformation from paper-driven processes to paperless can seem daunting, but the benefits of incorporating a Manufacturing Execution System (MES) are numerous, and include:

  • The elimination of the need for paper, saving endless time and financial resources
  • Full traceability of the process in an electronic format
  • Inherently less review time, as the MES is self-auditing
  • Quick analysis and characterization of the manufacturing process

Implementation of a paperless Manufacturing Execution System allows the operators to focus on the quality of the product and process – not on the paperwork.  An implemented MES enforces that the product is manufactured per the Device Master Record (DMR) and captures the actual manufacturing history regarding material consumption and production detail records (the “who, what, and when”). 

Exploring further, as MES is an end-to-end software manufacturing solution, what additional benefits are there to implementing this system into your shop floor?  How else can decision-makers justify MES adoption and implementation?  Although the following may not be at the top of an organization’s priority list now, these additional features/benefits of MES implementation will pay dividends in the future, and include:

  • NCR Execution Management and Defect Tracking. Because MES is directly on the shop floor, there is no better system to track defects and prevent mistakes in your production process.   Additionally, MES will automatically stop production if defects are discovered so that the error/defect doesn’t continue to be passed through the manufacturing process. 
  • Enforcing Procedures and Quality Specifications in Real Time.   One of the worst things a manufacturer can do is pass defects down the line.  This causes major issues in production, resource management, and public (and B2B) image – especially if the defect or error is passed on to the customer.
  • Systematic Go/No-Go. Systematic Go/No-Go can be applied to MES, which allows for the discovery of defects, procedure enforcement and immediate staff operator notification if error occurs.  Because of this systematic go/no-go, ambiguity is removed from the manufacturing process.
  • Close Gap Between Detection Point and Point of Failure.  If there are defects in the process, MES detection minimizes the cost and resource loss of the defect.
  • Controlled Rework Process Flows. When defects occur, they are often salvageable – with the correct re-work.  Implementation of the MES system adds structure and control when a rework is required.
  • Adding Statistical Processing Control. For process monitoring and/or characterization, an SPC can be added to the MES system.
  • Utilizing MES data for metrics and root cause analysis for failures – or to drive perfect quality.

Exploring paperless manufacturing is an opportunity for small-to-medium manufacturers to increase their competitive advantages. Stepping into the paperless revolution creates a more secure and more accurate process, while leading the way to greater revenues.

In partnership with Siemens, we at Seabrook recommend utilization and implementation of the CamstarTM Medical Device Suite.  Camstar™ Medical Device Suite is a leading solution in the medical device and diagnostics industry.  Known for error-proofing processes, paperless manufacturing and the creation of eDHR (Device History Records) and eBR (Batch Records), CamstarTM Medical Device Suite has a proven track record of helping companies excel in achieving their goals.   CamstarTM Medical Device Suite helps companies to accelerate innovation, reduce cost, and achieve the highest quality products – all while making compliance a by-product of the excellent manufacturing processes.

It has been our experience that companies that utilize the CamstarTM Medical Device Suite can quickly realize significant reduction in paper cost, cycle times, manufacturing-related complaints, scrap, and product review and release time.

As a leader in the industry, CamstarTM is very small-business friendly and serves a large customer base with great success! Details and much more information will be presented in a webinar hosted by Seabrook Technology Group and Siemens on Wednesday, April 10 2019 from 11:30 a.m.-12:15 p.m. EST.  Register for this FREE WEBINAR by visiting https://www.eventbrite.com/e/camstar-mes-for-medical-device-manufacturers-tickets-55155024162

FREE WEBINAR: Camstar MES for SMB Medical Device Manufacturers
DATE:  Wednesday, April 10 2019 / 11:30 a.m.-12:15 p.m. EST

Questions about Camstar MES or the FREE webinar? Simply email us: [email protected]

MESA

MESA, ISA & Seabrook

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Seabrook was delighted to meet with representatives of the Manufacturing Enterprise Solutions Association at the ISA’s first Food and Pharmaceutical Symposium to be held in Ireland. It was a great opportunity for us to catch up with MESA representatives and to discuss all that they have been doing in Ireland. We have always been extremely proud of our association with the organisation.

Desmond Savage gave a highly informative presentation on MESA during the food segment of the conference which was held at the Rochestown Park Hotel in Seabrook’s native Cork. The President of the ISA Ireland chapter, Alan Bateman, also recognised MESA’s support during his address to delegates. Pictured in the above photo taken at event are, from left to right, Ian Foley of Seabrook along with Wayne Bursey, Siemens, Peter Cullen, Rockwell Automation, Desmond Savage, ATS, and Andrew Daly, VisionID of the Ireland Special Interest Group.

MESA has some exciting events taking place over the next couple of weeks, including the Second International Virtual Internet of Things Conference in April and the Automation Conference and Expo in May. For a full list of MESA’s events, see http://www.mesa.org/en/newsevents/NewsEvents.asp

Manufacturing Execution Systems

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Manufacturing Execution Systems

Partnered with Siemens, Seabrook is a valued added reseller of the Camstar Medical Device Suite and has been a Camstar partner since 2006.

10 years on Camstar Medical Device Suite is still a leading solution in the medical device and diagnostics industry for error-proofing processes, paperless manufacturing and electronic device history records (eDHR). Emerging, midsize and global medical device and diagnostics organizations are faced with the challenge of balancing cost reductions and regulatory compliance while consistently producing high-quality products. Camstar Medical Device Suite has a proven track record of helping medical device and diagnostics companies excel in the face of these challenges.

Providing a powerful and flexible tool Camstar Medical Device Suite is a unique configuration of Camstar Enterprise platform. By effectively addressing the full range of business challenges that the industry faces, Camstar Medical Device Suite helps manufacturers become better, faster and cheaper. It does this by enabling you to build quality into the manufacturing process instead of testing quality coming out of the process, a mistake that often occurs in the manufacturing sector. Camstar Medical Device Suite has been deployed with powerful results in a variety of medical device product segments, such as diagnostics, orthopedics, cardiovascular, hospital and wound care, diabetes care, renal, blood care, vision and imaging. The solution is highly functional and flexible and provides an excellent user experience.

Benefits

  1. Proactively build quality into the manufacturing process
  2. Identify, analyze, solve and prevent problems while production continues
  3. Provide visibility into the performance of components, tests, etc.
  4. Enable you to understand fatigue impact, manual operation failure rates and time to ramp to quality
  5. Close the loop on continuous improvement initiatives
  6. Define, distribute and enforce process and engineering changes to any global factory

Quantifiable Value:

  1. $3.7M Recurring in Cost Reductions
  2. $1.6M (one-time) Inventory Reduction
  3. 5%-10% Yield Improvements
  4. 35% Increase in thruput (10k units)

Strategic Value:

  1. 100% reduction in Op Training Errors
  2. 75% Reduction in Field Actions
  3. 64% Reduction in Prod Inquiry Reports
  4. Enforced DFT Lowering Inventory/Lead Time

Key Values:

Paperless manufacturing

Replace manual paper manufacturing processes with proactive manufacturing execution that streamlines the process, delivering cost reductions and improved quality and compliance. The result is a complete electronic audit trail of all manufacturing activity and an electronic device history record. There is no paper, printing, moving or storage.

Automated enforcement and control Collect information and enforce business rules to achieve error-proof processes. Ensure the right procedures, operators, equipment and materials are used within specification and in the right sequence. Move to a review by exception product release process as a result of an automated self-auditing electronic device history record.

Lean and Six Sigma enablement

Lean and Six-Sigma initiatives are driven by data to establish a baseline, identify improvements, analyze results and control processes. Camstar Medical Device Suite provides the foundation by enabling you to collect integrated product, process and quality data in a structured electronic format in a matter of seconds. You can make your processes mistake proof with systemic enforcement to ensure control, closing the loop on continuous improvement initiatives.

Global process data management

Define, distribute and enforce process and engineering changes to any global factory. Complete audit trails make it possible to understand the impact of engineering change orders (ECOs) and the effectivity of corrective and preventive actions. Intelligent root cause analysis enables you to discover the true source of the problem by leveraging a growing knowledge base of granular product design, process design, manufacturing (as-built and inspection), field use and quality event data.

Containment management and forward/backward traceability

Use configurable searches such as where used analysis to identify suspect at-risk material based on unique criteria, such as a component lot, machine, operator, a specific shift, etc. Configure dynamic actions based on your business rules, then take quick action, such as hold, rework, material review board (MRB), quarantine, etc. All products, components and supplied materials are completely traceable.